Ready to rumble, Novartis? Roche targets melanoma-fighting combo market with new FDA nod

When Novartis ($NVS) bought GlaxoSmithKline's ($GSK) oncology business, the newest products were a pair of targeted melanoma drugs, Tafinlar and Mekinist. The two meds had racked up trial data showing they beat Roche's ($RHHBY) own targeted drug Zelboraf when used in tandem.

Now, Roche has its own tandem combo, and it could be a spoiler for the Novartis duo.

Roche nabbed FDA approval for Cotellic (cobimetinib) Tuesday, for use alongside Zelboraf in patients with BRAF V600-mutation-positive advanced melanoma. Cotellic is an MEK inhibitor, as Mekinist is. And Zelboraf was the first BRAF inhibitor, with Novartis' Tafinlar hitting the market several years later.

Roche sees the new combo approval as a way to jump-start Zelboraf sales, which have been flagging on new competition. The drug's global sales dropped by 25% for the first 9 months of 2015, to 158 million Swiss francs--and fell 40% in the U.S. If the combo succeeds, that would change; Cotellic alone has peak sales forecasts of $700 million-plus from some analysts.

In a key clinical trial, adding Cotellic to Zelboraf boosted progression-free survival to a median of 12.3 months from 7.2 months for Zelboraf alone. And 65% of combo patients were alive 17 months after starting treatment, compared with 50% for the Zelboraf-only group.

The Novartis combo also has Zelboraf-beating data, with a median overall survival of 25.6 months for the two-med treatment compared with 18 months for Zelboraf alone. The two-year survival rate for Tafinlar plus Mekinist was 51%, compared with 38% for Zelboraf monotherapy.

When Tafinlar won FDA approval in 2013, GSK undercut the price of Roche's drug at $7,600 per month compared with about $11,000 per month for Zelboraf. The list price of Mekinist at the time was $8,700 per month, putting the combo therapy at $15,300 monthly, or $183,600 per year.

The Zelboraf-Cotellic combo is reportedly priced at $17,600 per month, or about $211,000 per year.

The two targeted combos aren't the only competitors on the melanoma landscape. Bristol-Myers Squibb ($BMY) and Merck & Co. ($MRK) each have new immunotherapies for the disease in Opdivo and Keytruda, respectively. And Bristol-Myers now has an approval for Opdivo alongside its older melanoma treatment Yervoy, a combo that carries a list price of $256,000 per year, or $141,00 for a four-month treatment course.

But the Opdivo-Yervoy combo isn't approved for BRAF-positive cancer--just the opposite. Its FDA nod focused on "BRAF wild-type" melanoma, putting the Novartis and Roche pairs in an entirely different market.

- read the Roche release

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